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Two Studies for Patients with High Risk Prostate Cancer Testing Less Intense Treatment for Patients with a Low Gene Risk Score and Testing a More Intense Treatment for Patients with a High Gene Risk Score, The PREDICT-RT Trial

Trial Status: Active

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

Inclusion Criteria

  • PRIOR TO STEP 1 REGISTRATION
  • Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration
  • High-risk disease defined as having at least one or more of the following: * PSA > 20 ng/mL prior to starting ADT * cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) * Gleason score of 8-10 * Node positive by conventional imaging with a short axis of at least 1.0 cm
  • Appropriate stage for study entry based on the following diagnostic workup: * History/physical examination within 120 days prior to registration; * Bone imaging within 120 days prior to registration; ** Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible * CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only * Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by >= 10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure =< 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study
  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
  • Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
  • Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors (within 120 days prior to registration)
  • Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration) * For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility * Either a CrCl >= 30 ml/min or calculated glomerular filtration rate (GFR) >= 30 will make a patient eligible
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration) * Note: In subjects with Gilbert’s syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within 120 days prior to registration)
  • Serum albumin >= 3.0 g/dL (within 120 days prior to registration)
  • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count >= 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • PRIOR TO STEP 2 RANDOMIZATION
  • Confirmation of Decipher score
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs. Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol
  • For patients entering the Intensification Cohort ONLY: Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization

Exclusion Criteria

  • PRIOR TO STEP 1 REGISTRATION:
  • Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI)
  • Prior systemic chemotherapy within =< 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration
  • Prior radical prostatectomy
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Current use of 5-alpha reductase inhibitor. NOTE: If the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
  • History of any of the following: * Seizure disorder * Current severe or unstable angina * New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.) * History of any condition that in the opinion of the investigator, would preclude participation in this study
  • Evidence of any of the following at registration: * Active uncontrolled infection requiring IV antibiotics * Baseline severe hepatic impairment (Child Pugh Class C) * Inability to swallow oral pills * Any current condition that in the opinion of the investigator, would preclude participation in this study
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is =< 60 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT
  • PRIOR TO STEP 2 RANDOMIZATION:
  • Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration
  • For patients entering the Intensification Cohort ONLY: Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

Alaska

Fairbanks
Fairbanks Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-458-3043

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 501-686-8274

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-826-4673
Fremont
Washington Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-745-6433
Greenbrae
Marin General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-925-7325
Lancaster
City of Hope Antelope Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-826-4673
Los Angeles
Cedars Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-423-8965
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Marysville
Fremont - Rideout Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 530-749-4400
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-8839
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089
South Pasadena
City of Hope South Pasadena
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-826-4673
Torrance
Torrance Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-517-4665
Torrance Memorial Physician Network - Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-750-3300
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 530-582-6450

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Memorial Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-364-6700
UCHealth Memorial Hospital Central
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-365-2406
Edwards
Shaw Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-569-7429
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Poudre Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-297-6150
Greeley
UCHealth Greeley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Loveland
Medical Center of the Rockies
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-203-7083

Delaware

Dover
Bayhealth Hospital Kent Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-744-6755
Newark
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Medical Oncology Hematology Consultants PA
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Site Public Contact
Phone: 352-273-8010
Lakewood Ranch
GenesisCare USA - Lakewood Ranch
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Plantation
GenesisCare USA - Plantation
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700

Georgia

Atlanta
Emory Proton Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-251-2854
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-946-7447
Grady Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-489-9164

Illinois

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212
Chicago
Northwestern University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-695-1301
Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-942-5498
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Decatur
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Elmhurst
Elmhurst Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-758-5460
Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
Naperville
Edward Hospital / Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-646-6075
Peoria
OSF Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-528-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-352-5360

Iowa

Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Overland Park
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Wichita
Ascension Via Christi Hospitals Wichita
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-362-0070

Louisiana

Metairie
East Jefferson General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
New Orleans
Tulane University Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-988-6121

Maine

Bath
MaineHealth Coastal Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Portland
Maine Medical Center-Bramhall Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-885-7565
Rockport
Penobscot Bay Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8670
Sanford
MaineHealth Cancer Care Center of York County
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-459-1600
Scarborough
Maine Medical Center- Scarborough Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8090
South Portland
Maine Medical Partners - South Portland
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-396-8670

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 617-724-5200
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-726-5130

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Brighton
University of Michigan - Brighton Center for Specialty Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Brownstown
Henry Ford Cancer Institute-Downriver
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Clarkston
GenesisCare USA - Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Dearborn
Beaumont Hospital - Dearborn
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Henry Ford Medical Center-Fairlane
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Detroit
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Farmington Hills
GenesisCare USA - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Kalamazoo
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Macomb
GenesisCare USA - Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Madison Heights
GenesisCare USA - Madison Heights
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Novi
Henry Ford Medical Center-Columbus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Royal Oak
William Beaumont Hospital-Royal Oak
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Shelby Township
Henry Ford Macomb Health Center - Shelby Township
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-1784
Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Troy
GenesisCare USA - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
William Beaumont Hospital - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Albert Lea
Mayo Clinic Health System in Albert Lea
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Duluth
Miller-Dwan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Columbia
University of Missouri - Ellis Fischel
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-882-7440
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Kansas City
University of Kansas Cancer Center - North
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Saint Louis
Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606

Montana

Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

New Hampshire

Concord
New Hampshire Oncology Hematology PA-Concord
Status: ACTIVE
Contact: Site Public Contact
Phone: 603-224-2556
Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-639-6918
Manchester
Solinsky Center for Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-339-6484

New Jersey

Camden
Cooper Hospital University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 856-325-6757
Egg Harbor Township
AtlantiCare Surgery Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 609-748-7200
Hamilton
The Cancer Institute of New Jersey Hamilton
Status: ACTIVE
Contact: Site Public Contact
Phone: 609-631-6946
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-7356
Paramus
The Valley Hospital-Luckow Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-634-5792
Ridgewood
Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-634-5792
Toms River
Community Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-557-8294
Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Status: ACTIVE
Contact: Site Public Contact
Phone: 856-325-6757

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
Canandiaqua
Sands Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-396-6161
Flushing
The New York Hospital Medical Center of Queens
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Lake Success
Northwell Health / Center for Advanced Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 516-734-8896
New York
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-746-1848
Rochester
Highland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-464-5476

North Carolina

Cary
Duke Cancer Institute Cary
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-781-7070
Charlotte
Atrium Health Pineville / LCI-Pineville
Status: ACTIVE
Contact: Site Public Contact
Phone: 980-442-2000
Atrium Health University City / LCI-University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Levine Cancer Institute-Ballantyne
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Durham
Duke University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-275-3853
Raleigh
Duke Raleigh Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-862-5400
Wilmington
New Hanover Regional Medical Center / Zimmer Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-342-3000
Novant Health Cancer Institute Radiation Oncology - Wilmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-251-1839

Ohio

Akron
Summa Health System - Akron Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221
Barberton
Summa Health System - Barberton Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Medina
Summa Health Medina Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-375-4221

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-220-4937
Tualatin
Legacy Meridian Park Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-1742

Pennsylvania

Altoona
UPMC Altoona
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Beaver
UPMC-Heritage Valley Health System Beaver
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-389-5208
Carlisle
Carlisle Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Chadds Ford
Christiana Care Health System-Concord Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Erie
Saint Vincent Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 814-452-5000
UPMC Hillman Cancer Center Erie
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-389-5208
Farrell
UPMC Cancer Center at UPMC Horizon
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-838-1900
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-724-6765
Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-531-3779
Jefferson Hills
Jefferson Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-359-3043
Johnstown
UPMC-Johnstown / John P. Murtha Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 814-534-4724
McKeesport
UPMC Cancer Center at UPMC McKeesport
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073
Mechanicsburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-389-5208
Monroeville
Forbes Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-858-7746
UPMC Cancer Center - Monroeville
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Moon Township
UPMC-Coraopolis / Heritage Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-604-2020
Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-600-9151
Pittsburgh
Allegheny General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-284-2000
UPMC-Magee Womens Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-2811
UPMC-Passavant Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-502-3920
UPMC-Saint Margaret
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-784-4900
UPMC-Shadyside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-621-2334
West Penn Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-578-5000
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
Seneca
UPMC Cancer Center at UPMC Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 814-676-7900
Uniontown
UPMC Uniontown Hospital Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-437-2503
Washington
UPMC Washington Hospital Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-223-3788
West Reading
Reading Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-988-9323
Wexford
Wexford Health and Wellness Pavilion
Status: ACTIVE
Contact: Site Public Contact
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
York
UPMC Memorial
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-724-6760

Rhode Island

Providence
Rhode Island Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321
Greenville
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Greenwood
Self Regional Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-725-4771
Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Myrtle Beach
Carolina Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-460-2657
Spartanburg
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104

Tennessee

Knoxville
Thompson Cancer Survival Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-331-1812

Texas

Conroe
MD Anderson in The Woodlands
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-632-6789
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
MD Anderson West Houston
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
Sugar Land
MD Anderson in Sugar Land
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-855-4100
Logan
Logan Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-716-6400
Murray
Intermountain Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-387-7426
Provo
Utah Valley Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-357-7965
Riverton
Riverton Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-507-3950
Saint George
Saint George Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 833-321-3332
Salt Lake City
LDS Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-408-1347
Utah Cancer Specialists-Salt Lake City
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-933-6070

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu
Saint Johnsbury
Norris Cotton Cancer Center-North
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-473-4100

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Washington

Vancouver
Legacy Cancer Institute Medical Oncology and Day Treatment
Status: ACTIVE
Contact: Site Public Contact
Legacy Salmon Creek Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150

West Virginia

Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-243-6442

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 715-623-9869
Ashland
Northwest Wisconsin Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Milwaukee
Zablocki Veterans Administration Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-469-6614
Wausau
Aspirus Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-405-6866
Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
Status: ACTIVE
Contact: Site Public Contact
Phone: 715-422-7718

PRIMARY OBJECTIVES:

I. To determine whether men with National Comprehensive Cancer Network (NCCN) high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (=< 0.85) can be treated with 12 months androgen deprivation therapy (ADT) plus radiation therapy (RT) instead of 24 months ADT+RT and experience non-inferior metastasis-free survival. (De-intensification study)

II. To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (> 0.85) or have node-positive disease by conventional imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide added to the standard of RT plus 24 month ADT. (Intensification study)

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) between the standard of care (RT plus 24 months of ADT) and either the de-intensification (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

II. To compare time to prostate specific antigen (PSA) failure or start of salvage treatment between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

III. To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

IV. To compare MFS judged based on either standard or molecular imaging between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

V. To compare prostate cancer-specific mortality between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

VI. To compare testosterone levels at the time of PSA failure and metastases between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

VII. To compare time to testosterone recovery (defined as a T > 200) between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

VIII. To compare adverse events, both clinician-reported using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and patient-reported using Patient Reported Outcome (PRO)-CTCAE items, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

CORRELATIVE STUDIES OBJECTIVE:

I. To compare extra-prostatic uptake on the positron emission tomography (PET)-CT between the standard of care (RT plus 24 months of ADT) and intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification study)

EXPLORATORY OBJECTIVES:

I. To compare changes in cardio-metabolic markers, including body mass index, and waist circumference, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

II. To determine a machine learning/artificial intelligence algorithm for radiotherapy quality assurance. (De-intensification and Intensification studies)

III. To perform future translational correlative studies using biological and imaging data. (De-intensification and intensification studies)

PATIENT-REPORTED OUTCOMES OBJECTIVES:

PRIMARY OBJECTIVES:

I. To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study)

II. To compare fatigue, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

SECONDARY OBJECTIVES:

I. To compare depression, as measured by the PROMIS-depression, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study)

II. To compare depression, as measured by the PROMIS-depression, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

EXPLORATORY OBJECTIVES:

I. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study)

II. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study)

III. To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study)

IV. To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

V. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

VI. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

OUTLINE: Patients are randomized to 1 of 4 arms.

DE-INTENSIFICATION STUDY (DECIPHER SCORE =< 0.85):

ARM I: Patients undergo radiation therapy (RT) over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.

INTENSIFICATION STUDY (DECIPHER SCORE > 0.85 OR NODE POSITIVE):

ARM III: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide orally (PO) once daily (QD). Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Paul L. Nguyen

  • Primary ID NRG-GU009
  • Secondary IDs NCI-2020-04705
  • Clinicaltrials.gov ID NCT04513717